Emails. It’s a love – hate
relationship. We loathe a full inbox when
returning from vacation because those emails represent how far behind we are with
our work. Even during normal business hours,
nonstop emails can draw our attention when we are trying to close out our workday. It can be hard to turn off the information
flow.
On the other hand, emails have become a convenient and expedient way to
communicate with others. Emails allow us
to deliver valuable study information rapidly across sponsors, CROs, study
sites, and vendors. Much of our clinical
trial work is accomplished via email. Now,
in this sudden era of the COVID-19 pandemic, we are going to rely even more on
email and other virtual technologies to keep us moving forward.
Correspondence is an important component in reconstructing how a trial
was conducted.
Clinical trial teams generate a tremendous amount of correspondence.
While it’s easy to define letters, team
meeting agendas, meeting minutes, and telephone call reports as “relevant” correspondence
(to use the FDA’s term in ICH E6(R2)), what about all those emails? Surely, they don’t all belong in the
TMF! It can be very confusing. Some studies ask all team members to save
every email, and while some sponsors may have other business reasons for saving
all project related email, what do regulatory agencies want in the TMF?
In a 2012 GCP Forum, the MHRA acknowledged the email dilemma stating
that “some CRO organizations rely solely on email correspondence to confirm sponsor
approval of processes, documents, and decisions.” The MHRA
stated that:
“Only relevant correspondence that is
necessary for reconstruction of key activities and decisions (for example, the
medical monitor allows an ineligible subject to remain in the trial) or that
contains other significant information must be retained. If some correspondence
is not retained (particularly certain emails which may not add any value by
being retained, such as, email correspondence between investigator site staff
and the trial monitor discussing holidays or suitable hotels to stay in near
the site), then there should be a formal process to assist individuals in the
evaluation of whether it contributes to the reconstruction of the trial or not.”
How to determine relevance?
Does your organization or project team provide guidance on how to
determine which emails are relevant and should be filed in the TMF? ICH E6(R2) provides some helpful tips when
setting relevancy criteria, but your organization may want to expand the
criteria to add clarity. Additional context and examples are added in italics as
suggestions to consider:
Agreements – Between two or more organizations, or persons
that significantly impact the study.
Significant discussions regarding trial administration – Implementation
of important changes to the trial oversight, monitoring, and study assessments. Emails that demonstrate follow-through
actions should be included.
Protocol violations – Either subject-specific or significant general. Subject-specific protocol violations should
include the agreed plans for dispensation of the subject.
Trial conduct – Includes subject eligibility,
allowance of rescreening, and follow through actions.
Adverse event reporting – Applies to specific subject AE,
pregnancy, or significant discussion of general AE management. Include evidence
of follow through actions where appropriate.
Who files relevant emails in the TMF?
Once you’ve determined that an email is relevant and does need to be
filed, does your organization or project team have clear guidance on who is
responsible for filing it? We don’t want everyone who receives an email about
the eligibility of a subject to file it in the TMF because that will result in
duplicates. Will the individual who originated the email be responsible for
filing it or will specific team members be asked to file the relevant emails? Are
the instructions clear enough and roles understood sufficiently to avoid filing
duplicate emails?
Where can you find best practices?
Does your organization or project team provide guidance on best email
authoring practices? Drafting guides
that add tips for writing clear and concise emails with a professional tone can
be helpful. We’ve all heard the adage to
think about how your email would look if it appeared on the cover of the NY
Times.
What more should teams think about?
Circumstances can change quickly in a clinical trial, prompting the
study team to adjust their study conduct, much like we are seeing with the
current COVID-19 pandemic. While emails may
be the quickest way to get essential instructions to the sites when a change is
required, always remember to follow those up with updates to the formal process
documents. Big or small, any changes
from the previous practice, as described in the protocol, operations manual,
monitoring plan, or other relevant documents, means that the team will want to
update the respective procedure documents.
Emails are a valuable tool in clinical trials but can be tricky to
manage. With the proper guidance and instruction, you can set your clinical
trial teams up for success and ensure that only truly relevant correspondence
winds up in your TMF.
Contact LMK Clinical
Research Consulting today
for a complimentary consultation and take the first step toward achieving a
healthy, successful, and compliant TMF in 2020.
Sources Used:
ICH E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
Guidance for Industry
MHRA online cited 02Apr2020: http://forums.mhra.gov.uk/showthread.php?1665-MHRA-produced-FAQs-for-Trial-Master-Files-(TMF)-and-Archiving